Menveo (meningococcal-groups A, C, W-135 and Y oligosaccharide CRM197 conjugate vaccine) / GSK - LARVOL DELTA

VAC087: A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 With Matrix-M in Combination With R21/Matrix-M (clinicaltrials.gov) - P2 | N=360 | Active, not recruiting | Sponsor: University of Oxford | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Malaria

IM-101_MG_2.1: A Phase 1b/2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of IM-101 in Adult Participants with Generalized Myasthenia Gravis and Ocular Myasthenia Gravis (clinicaltrialsregister.eu) - P1/2 | N=83 | Not yet recruiting | Sponsor: Immunabs Inc.

New P1/2 trial • CNS Disorders • Myasthenia Gravis

Use of the GSK MenACWY-CRM/MenB-4C Pentavalent Meningococcal Vaccine Among Persons Aged ≥10 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2025. (PubMed, MMWR Morb Mortal Wkly Rep) - "Two quadrivalent (serogroups A, C, W, and Y) meningococcal conjugate vaccines (MenACWY) (MenACWY-CRM [Menveo, GSK] and MenACWY-TT [MenQuadfi, Sanofi Pasteur]) and two serogroup B meningococcal vaccines (MenB) (MenB-4C [Bexsero, GSK] and MenB-FHbp [Trumenba, Pfizer]) are licensed for use in the United States and recommended by CDC's Advisory Committee on Immunization Practices (ACIP)...On February 14, 2025, the Food and Drug Administration licensed a second pentavalent MenABCWY vaccine (MenACWY-CRM/MenB-4C [Penmenvy, GSK]) for prevention of invasive disease caused by N. meningitidis serogroups A, B, C, W, and Y in persons aged 10-25 years, the same indication for which MenACWY-TT/MenB-FHbp is licensed...Different manufacturers' serogroup B-targeting vaccines are not interchangeable; therefore, when MenACWY-CRM/MenB-4C is used, MenB-4C should be used for the other MenB doses. This report summarizes evidence considered for these recommendations and provides clinical..."

Clinical guideline • Journal • Immunology • Infectious Disease • Meningococcal Infections • Primary Immunodeficiency

HOPE II: Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV. (clinicaltrials.gov) - P4 | N=750 | Active, not recruiting | Sponsor: Massachusetts General Hospital | Trial primary completion date: Apr 2026 ➔ Dec 2026 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Oncology

H06_04TP: Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children (clinicaltrials.gov) - P2 | N=528 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P2 trial

A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (clinicaltrials.gov) - P1 | N=551 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion

A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever (clinicaltrials.gov) - P1/2 | N=155 | Completed | Sponsor: GlaxoSmithKline | Recruiting ➔ Completed

Trial completion • Infectious Disease

Immunogenicity and Safety of Meningococcal Conjugate Vaccine (EG-MCV4) in Healthy Adults Aged 19 to 55 Years Old (clinicaltrials.gov) - P2/3 | N=1123 | Recruiting | Sponsor: EyeGene Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Meningococcal Infections

Immunogenicity and Safety of Meningococcal Conjugate Vaccine (EG-MCV4) in Healthy Adults Aged 19 to 55 Years Old (clinicaltrials.gov) - P2/3 | N=1123 | Not yet recruiting | Sponsor: EyeGene Inc.

New P2/3 trial • Infectious Disease • Meningococcal Infections

VAC087: A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 With Matrix-M in Combination With R21/Matrix-M (clinicaltrials.gov) - P2 | N=360 | Not yet recruiting | Sponsor: University of Oxford

New P2 trial • Infectious Disease • Malaria

Investigating a Vaccine Against COVID-19 (clinicaltrials.gov) - P2/3 | N=10811 | Completed | Sponsor: University of Oxford | Active, not recruiting ➔ Completed | Trial completion date: Mar 2024 ➔ Feb 2025 | Trial primary completion date: Mar 2024 ➔ Feb 2025

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents (clinicaltrials.gov) - P1/2 | N=1215 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Meningococcal Infections

Penmenvy - a second pentavalent meningococcal vaccine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Infectious Disease • Meningococcal Infections

Study of immunogenicity and safety of MenQuadfi® as a booster vaccine in toddlers 12 to 23 months, regardless of the quadrivalent meningococcal conjugate vaccine used for priming in infancy. (clinicaltrialsregister.eu) - P4 | N=180 | Sponsor: Sanofi Pasteur

New P4 trial • Dermatology • Infectious Disease • Meningococcal Infections

A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (clinicaltrials.gov) - P1 | N=552 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | Phase classification: P1/2 ➔ P1

Enrollment closed • Phase classification

HOPE II: Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV. (clinicaltrials.gov) - P4 | N=750 | Recruiting | Sponsor: Massachusetts General Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease • Oncology

A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults (clinicaltrials.gov) - P1/2 | N=1429 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Meningococcal Infections

Analytical Challenges in Novel Pentavalent Meningococcal Conjugate Vaccine (A, C, Y, W, X). (PubMed, Vaccines (Basel)) - "Well-known meningococcal vaccines such as MenAfriVac, Nimenrix, Menveo, and MenQuadfi are licensed in various parts of the world and have been successful. Additional analytical challenges include the impact of excipients, potential interference from serogroups, selection and establishment of standards, age-dependent behavior of biomolecules indicated by molecular size distributions, and process-driven variations. This article explains the analytical insights gained (polysaccharide content, free saccharide, free proteins, MSD) during the development of the MenFive vaccine and highlights the crucial gaps and challenges in testing."

Journal • Review • CNS Disorders • Infectious Disease • Meningococcal Infections • Tetanus

Interim safety data from a phase 1/2a, randomized, controlled, observer-blind trial to evaluate the safety, reactogenicity and immunogenicity of a trivalent vaccine against invasive nontyphoidal Salmonellosis (iNTS) and Typhoid Fever in healthy . (ASTMH 2024) - "In stage 1, 50 European adults were randomized in a 2:2:1 ratio to receive either iNTS-TCV vaccine and concomitant saline in different arms, or separate iNTS-GMMA and TCV vaccines in different arms, or placebo and saline in different arms intramuscularly, on Days 1, 57 and 169...Menveo, Boostrix and Typhim Vi are administered as controls for the 1 st , 2 nd and 3 rd doses respectively...In conclusion, based on available data, the anticipated benefit/risk profile of the iNTS-TCV vaccine continues to be positive, with no safety concerns precluding further clinical development. First immunogenicity results are expected later in 2024 and would be presented at the congress."

Clinical • P1/2 data • Fatigue • Infectious Disease • Musculoskeletal Pain • Pain

Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age (clinicaltrials.gov) - P3 | N=943 | Completed | Sponsor: GlaxoSmithKline | Trial completion date: Jul 2024 ➔ Nov 2023

Trial completion date • Infectious Disease • Meningococcal Infections

Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy (clinicaltrials.gov) - P4 | N=71 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Completed | N=180 ➔ 71

Enrollment change • Trial completion • Infectious Disease • Meningococcal Infections

An Open Label Study of IgG Fc Glycan Composition in Human Immunity (clinicaltrials.gov) - P1 | N=129 | Terminated | Sponsor: Rockefeller University | Phase classification: P=N/A ➔ P1 | Active, not recruiting ➔ Terminated; Inadequate enrollment

Phase classification • Trial termination

Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents (clinicaltrials.gov) - P1/2 | N=1220 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Meningococcal Infections

Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents (clinicaltrials.gov) - P1/2 | N=1220 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Initiation date: Jan 2023 ➔ Oct 2023

Trial initiation date • Infectious Disease • Meningococcal Infections

HOPE II: Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV. (clinicaltrials.gov) - P4 | N=750 | Not yet recruiting | Sponsor: Massachusetts General Hospital

New P4 trial • Human Immunodeficiency Virus • Infectious Disease • Oncology